某院门诊妊娠患者超说明书用药情况分析

Investigation and analysis of off-label drug use prescriptions in pregnant outpatients

目的:通过回顾性研究某院门诊妊娠患者的超说明书用药的情况,促进妊娠患者的安全及合理用药。方法:分层随机抽取某院门诊临床诊断涉及"妊娠"但不包括"正常妊娠监督"和"未确认妊娠"的处方,按照药品说明书,对处方中的用药医嘱分别从适应证、禁忌证、给药途径、给药频次、给药剂量和适用人群等方面判断其是否超说明书用药并分析。结果:共抽取2 872份门诊处方,用药医嘱3 926条,用药品种88种。其中,涉及超说明书用药处方共689张(23.99%)、用药医嘱827条(21.06%)及药物品种15种(17.04%)。主要的超说明书用药类型为超剂量用药(60.67%)、超适用人群用药(19.98%)和超禁忌证用药(18.61%)。超说明书用药发生率前3位的药物种类依次为女性生殖系统用药(61.91%),电解质、酸碱平衡及营养药(23.82%)和中成药(12.82%)。结论:妊娠患者超说明书用药发生率较高,应积极推进妊娠患者的超说明书用药的循证研究、建立超说明书用药分级分类管理制度,确保妊娠患者的用药安全。

OBJECTIVE To investigate the off-label drug uses in pregnant outpatients of our hospital,so as to promote rational medication use.METHODS The prescriptions from the outpatients of pregnant women were investigated randomly.According to the introductions of drug,the prescriptions of off-label uses were picked out and analyzed in the following perspectives,indications,contraindications,routes of administration and populations.RESULTS Totally 2 872 prescriptions for outpatient were selected involving 3 926 medication records and 88 kinds of drugs.Among them there were 689 prescriptions（23.99%）,827 medication records（21.06%）and 15 kinds of drugs（17.04%）involved in off-label uses.The main types of off-label uses were dosage（60.67%）,populations（19.98%）and contraindications（18.61%）.The top 3 drug categories of off-label drug uses were female reproductive system（61.91%）,electrolyte,acid and alkali balance and nutrition（23.82%）and traditional Chinese medicine（12.82%）.CONCLUSION Frequency of off-label drug use in pregnant women is much higher.Evidence-based research of off-label use should be promoted in pregnant women to set up the classification management to ensure the safe medicine uses.Manufacturers should improve and standardize the drug instructions.